Treatment of Clonorchiasis in Guangxi With Albendazole, Tribendimidine, and Praziquantel

Recruiting now · Phase 4

Conditions studied: Clonorchiasis

In brief

The goal of this clinical trial is to evaluate and compare the efficacy and safety of three commonly used antiparasitic drugs-albendazole, tribendimidine, and praziquantel-for the treatment of clonorchiasis, a liver fluke infection acquired by consuming raw or undercooked freshwater fish. This study aims to answer the following primary questions: How effective is each drug in achieving parasitological cure, as measured by clearance of Clonorchis sinensis eggs in stool? What types and frequencies of adverse events are associated with each treatment? Participants in this randomized, open-label trial will: Be randomly assigned to receive one of the three study drugs according to a predefined dosing regimen. Provide stool samples before treatment and at follow-up to assess for Clonorchis sinensis eggs. Undergo a second round of the same treatment regimen and repeated stool examination if eggs are still detected after the first course. Attend follow-up visits, which include symptom assessment, blood tests (hematology and liver function), and abdominal ultrasonography focusing on hepatobiliary changes. Report any side effects, discomfort, or adverse reactions experienced during or after treatment. The findings from this study will help inform optimal therapeutic strategies for clonorchiasis in outpatient clinical settings.

Key facts

Study ID: NCT07074444
Run by: First Affiliated Hospital of Guangxi Medical University
People needed: 318
Starts: 2025-07-22
Expected to finish: 2026-12-31
Last updated by the study team: 2025-08-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Adults aged ≥18 years.
Confirmed diagnosis of Clonorchis sinensis infection based on the latest Expert Consensus on Diagnosis and Treatment of Food-Borne Parasitic Diseases (2023): detection of eggs or adult worms in stool or bile drainage fluid.
Willing and able to provide written informed consent and comply with study procedures.

You may not qualify if…

Known hypersensitivity or allergy to albendazole, praziquantel, or tribendimidine.
Electrocardiogram (ECG)-confirmed supraventricular tachycardia or atrial fibrillation.
Clinically or radiologically diagnosed neurocysticercosis (brain or spinal cord) or ocular cysticercosis (eye or orbit).
Presence of gallbladder stones or biliary tract obstruction as confirmed by abdominal ultrasound.
Individuals with severe hepatic, renal, or cardiac dysfunction, or with active peptic ulcer disease.
Pregnant or breastfeeding individuals, or those of reproductive potential (male or female) who are unwilling to use effective contraception during the study period and for 3 months following the last dose of study medication.
Anticipated loss to follow-up due to relocation, withdrawal of consent, or other factors affecting adherence to the study protocol.

Where it is running

The First Affiliated Hospital of Guangxi Medical University — Nanning, Guangxi, China (enrolling)
People's Hospital of Guangxi Zhuang Autonomous Region — Nanning, Guangxi, China

Full record on ClinicalTrials.gov

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